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A Study of ASP2215 Versus Salvage Chemotherapy In Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase 3 (FLT3) Mutation

NCT03182244 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 276

Last updated 2026-05-05

Study results available
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Summary

The purpose of this study was to determine the clinical benefit of ASP2215 therapy in participants with FMS-like tyrosine kinase (FLT3) mutated AML who were refractory to or had relapse after first-line AML therapy as shown with overall survival (OS) compared to salvage chemotherapy. In addition, this study evaluated safety as well as determined the overall efficacy in event-free survival (EFS) and complete remission (CR) rate of ASP2215 compared to salvage chemotherapy.

Conditions

  • AML With FLT3 Mutation

Interventions

DRUG

G-CSF

Once daily IV/SC injection.

DRUG

Fludarabine

Once daily IV injection.

DRUG

Gilteritinib

Tablet administered orally once daily.

DRUG

Cytarabine

Once/twice daily Intravenously (IV)/subcutaneously (SC).

DRUG

Mitoxantrone

Once daily IV injection.

DRUG

Etoposide

Once daily IV injection.

Sponsors & Collaborators

  • Astellas Pharma Inc

    lead INDUSTRY

Principal Investigators

  • Medical Director · Astellas Pharma Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-25
Primary Completion
2023-12-25
Completion
2027-03-31
FDA Drug
Yes

Countries

  • China
  • Malaysia
  • Russia
  • Singapore
  • Thailand

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03182244 on ClinicalTrials.gov